This invention relates to a vascular occlusion device and more particularly to a balloon occlusion device for temporarily controlling the flow of blood through a graft or blood vessel in a human body.
New surgical techniques such as bypass of arterial stenoses or occlusions and replacement of segments of arteries involved by aneurysms or reconstruction following trauma, etc. involving the entire arterial tree has led to operation on more delicate and fragile vessels (e.g. coronary arteries, internal mammary arteries, saphenous veins) and therefore a need for a new, less traumatic, improved vascular occlusion device.
For example, in my copending U.S. patent application entitled "Implantable Graft Material and Method for its Fabrication" U.S. Ser. No. 07/235,510 filed Aug. 24, 1988, now abandoned I disclose a tubular graft which is suitable for blood vessel substitution such as those required for a variety of vascular procedures. However, such substitutions often require a temporary interruption in the flow of blood.
Vascular clamps of a variety of designs have been used to temporarily occlude blood vessels; however, they have been known to produce enough trauma to the vessel that disruption bleeding and early closure are known to have resulted from their use. This invention allows the least amount of pressure to occlude these vessels to stop blood flow and therefore is the least traumatic.
One approach to temporarily close the blood vessels providing arterial blood, without leaving the vessel more susceptible to thrombosis is disclosed in the U.S. Pat. No. 3,538,917 of Robert G. Selker. The Balloon Occlusion Clip disclosed therein is adapted to be positioned about the vessel for use in 2-4 mm vessels in intracranial surgery. An inflatable member is shaped to surround at least a portion of the vessel and upon inflation, occludes the vessel.
The occlusion clips overcome many of the disadvantages of metallic clips used in surgery. For example such clips may be used to completely occlude a vessel without damaging the internal lining of the vessel. However, such clips do not satisfy the needs required for many of today's vascular and cardiac surgical techniques. For example, they do not include means for maintaining a desired degree of occlusion, thus freeing the hands of the surgeon, are not adapted for positioning in a remote area without interfering with the surgical operation, and do not include means for preventing slippage along the vessel without damaging the vessel or actually slipping off the vessel. Applicant's device completely surrounds the vessel and is used in areas other than intracranial surgery.
A U.S. Patent of Adel A. Ibrahim U.S. Pat. No. 4,597,389 discloses a device for positioning a surgical balloon in a remote area of a human body. However, these devices are not adapted to pass over or around the conduit. They do not include means for preventing slippage along a vessel.